| CTRI Number |
CTRI/2020/04/024599 [Registered on: 13/04/2020] Trial Registered Prospectively |
| Last Modified On: |
01/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Compare a new algorithm of new device " Elisar AVA" to test central vision( within 10 degrees) with already existing device "Humphrey visual field analyzer |
|
Scientific Title of Study
|
Comparison of the 10-2 full threshold, 10-2 ZEST, 10-2 fast algorithm Elisar AVATM with corresponding algorithm of 10-2 of Humphrey visual field analyzer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maheswari Srinivasan |
| Designation |
Manager , Clinical sciences |
| Affiliation |
Dr.Agarwals eye hospitals. |
| Address |
First floor, Glaucoma department, Autoperimetry room, Room no: 118, No 222, TTK Road,
Chennai
India.
First floor, Glaucoma department, Autoperimetry room, Room no: 118, No 222, TTK Road,
Chennai
India.
Chennai
TAMIL NADU
600006.
India |
| Phone |
09841661134 |
| Fax |
|
| Email |
maheswari.srinivasan@dragarwal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Maheswari Srinivasan |
| Designation |
Manager , Clinical sciences |
| Affiliation |
Dr.Agarwals eye hospitals. |
| Address |
First floor, Glaucoma department, Autoperimetry room, Room no: 118, No 222, TTK Road,
Chennai
India.
First floor, Glaucoma department, Autoperimetry room, Room no: 118, No 222, TTK Road,
Chennai
India.
Chennai
TAMIL NADU
600006.
India |
| Phone |
09841661134 |
| Fax |
|
| Email |
maheswari.srinivasan@dragarwal.com |
|
Details of Contact Person
Public Query
|
| Name |
Maheswari Srinivasan |
| Designation |
Manager , Clinical sciences |
| Affiliation |
Dr.Agarwals eye hospitals. |
| Address |
First floor, Glaucoma department, Autoperimetry room, Room no: 118, No 222, TTK Road,
Chennai
India.
First floor, Glaucoma department, Autoperimetry room, Room no: 118, No 222, TTK Road,
Chennai
India.
Chennai
TAMIL NADU
600006.
India |
| Phone |
09841661134 |
| Fax |
|
| Email |
maheswari.srinivasan@dragarwal.com |
|
|
Source of Monetary or Material Support
|
| Dr. Agarwals eye hospitals, No.222, TTK Road, Chennai-600018 Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Dr Amar Agarwal |
| Address |
First floor, Glaucoma department, Autoperimetry room, Room no: 188, No 222, TTK road, Chennai |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Maheswari Srinivasan |
Dr Agarwal s Eye hospitals |
First floor Glaucoma department Autoperimetry room Room No 118
No 222 TTK Road Chennai
Chennai
TAMIL NADU |
09841661134
maheswari.srinivasan@dragarwal.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Agarwals eye hospital institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H409||Unspecified glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Controls: 1. Cup disc ratio of less than 0.5.
2. IOP less than 20 mm Hg
3. Visual acuity better than 6/12 |
|
| ExclusionCriteria |
| Details |
Patients who had undergone ocular surgeries (other than cataract surgery), patients with ocular disease, amblyopia, neurological disorders will be excluded from the study.
Patients using a miotic drug will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish the equivalence between threshold estimates of 10-2 Elisar AVA with the 10-2 of Humphrey visual field analyser |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish the equivalence in mean deviation and pattern standard deviation between threshold estimates of 10-2 Elisar AVA with the 10-2 of Humphrey visual field analyser |
45 days |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose: The study aims to prove the equivalence of threshold estimates of 10-2 full threshold algorithm, 10-2 Elisar ZEST and 10-2 Elisar fast of AVATM with the corresponding algorithm of an established, industry-recognized visual field analyzer (Zeiss Humphrey Field Analyzer, or HFA).
Description of the study: Cross-sectional study to compare the
threshold estimates of 10-2 full threshold algorithm, 10-2 Elisar ZEST the algorithm, 10-2 Elisar fast algorithm of AVATM with the
corresponding algorithm of Zeiss Humphrey visual field analyzer (HFA)in both a the healthy control group and a study group exhibiting field loss (secondary to
glaucoma or non-glaucoma conditions). Study duration: 45 days Study design: A cross-sectional study. Inclusion criteria: Best-corrected visual acuity better than 6/12; Cup disc ratio less than 0.5 for controls. Best-corrected visual acuity better than 6/12; cup disc ratio more than 0.5 for glaucoma. Exclusion criteria: Patients who are under miotic therapy will be excluded from the study. Methodology: The control group will undergo dilation
followed by random execution of both 10-2 full threshold of AVATM and
10-2 full threshold of HFA trial procedures.
The glaucoma group and the other conditions group will undergo
gonioscopy and applanation tonometry; patients with open angles will be dilated
prior to random execution of AVATM and HFA trial procedures. For
Patients with closed angles the trial will be done with undilated pupils. Analysis: ICC and Bland Altman plots will be made to compare the threshold estimates of 10-2 of Elisar AVATM and the 10-2 of Humphrey visual field analyzer
|